山东省医疗器械和药品包装检验研究院 a. 医用电器质量评价中心；b. 电磁兼容质量评价中心，山东 济南 250101
Current Situation Analysis of Information Security of Medical Device Software
HAO Pengfeia, LI Qingyub, CHAI Ruia, LI Yaoa, CHEN Tiantiana, ZHANG Kea
a. Medical Electrical Quality Evaluation Center; b. EMC Quality Evaluation Center, Shandong Institute of Medical Device and
Pharmaceutical Packaging Inspection, Jinan Shandong 250101, China
Abstract：The number of medical device software has surged in recent years. While making great progress in medical technology
innovation and application quality, it has also caused many new risks, especially information security issues. The security research
of medical device software is particularly important because of the particularity of its application object. This study randomly
selected 100 sets of test samples with remote network service capability in our laboratory in the past three years, and analyzed their
information security vulnerabilities. The development and testing status of more than 60 enterprises was investigated, and security
suggestions for information security risks was put forward. This study has played a prompt role in improving the importance of
medical device software security in the industry. We hope to promote colleagues in the industry to jointly establish and improve the
safety evaluation method of medical device software products, to ensure the information security of medical device software before it
goes public, and to jointly create a safe medical environment.
郝鹏飞a，李庆雨b，柴蕊a，李瑶a，陈甜甜a，张克a. 医疗器械软件信息安全现状分析[J]. 中国医疗设备, 2023, 38(7): 120-123.
HAO Pengfeia, LI Qingyub, CHAI Ruia, LI Yaoa, CHEN Tiantiana, ZHANG Kea. Current Situation Analysis of Information Security of Medical Device Software. China Medical Devices, 2023, 38(7): 120-123.
